Open-Label Treatment With Duloxetine Hydrochloride Once-Daily Dosing for Evaluation of Stabilization Dose in Patients With Major Depression

This study has been completed.

First Received: July 31, 2002 Last Updated: July 18, 2006 History of Changes

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00042562

Purpose

The purposes of this study are to determine:

The safety of duloxetine and any side effects that might be associated with it.

Whether duloxetine can help patients with major depression.

The safety associated with switching from a medication you may be taking for depression to taking duloxetine.

It is possible that information collected during this study will be analyzed by the sponsor in the future to evaluate duloxetine for other possible uses or for other medical or scientific purposes other than those currently proposed.

Condition	Intervention	Phase
Major Depressive Disorder	Drug: duloxetine	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Open-Label Treatment With Duloxetine Hydrochloride Once-Daily Dosing for Evaluation of Stabilization Dose in Patients With Major Depression

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Duloxetine Duloxetine hydrochloride

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Study Start Date:	December 2002
Estimated Study Completion Date:	December 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

You must be at least 18 years old.
You must have been diagnosed with major depressive disorder.
You must be able to visit the doctor's office once a week to once every 2 weeks for a total of 14 weeks

Exclusion Criteria:

You are a woman and are pregnant or breastfeeding.
You have a current or previous major psychiatric disorder other than depression, such as bipolar disorder, schizophrenia, or other psychotic disorder.
You have had a primary diagnosis of an anxiety disorder within the past 6 months.
You have a history of alcohol or drug dependence or abuse within the past 6 months.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00042562

Locations

United States, California

Los Angeles, California, United States

Carlsbad, California, United States

Stanford, California, United States
United States, Connecticut

Cromwell, Connecticut, United States
United States, Florida

Coral Springs, Florida, United States

Gainesville, Florida, United States

Miami, Florida, United States
United States, Georgia

Atlanta, Georgia, United States
United States, Maine

Bangor, Maine, United States
United States, Massachusetts

Boston, Massachusetts, United States
United States, New York

Rochester, New York, United States

New York, New York, United States
United States, Ohio

Cincinnati, Ohio, United States
United States, Pennsylvania

Philadelphia, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States
United States, Texas

Dallas, Texas, United States

Houston, Texas, United States

San Antonio, Texas, United States
United States, Virginia

Falls Church, Virginia, United States

Richmond, Virginia, United States

Charlottesville, Virginia, United States
United States, Washington

Seattle, Washington, United States
United States, Wisconsin

West Allis, Wisconsin, United States

Sponsors and Collaborators

Eli Lilly and Company

More Information

No publications provided

Study ID Numbers:	6476, F1J-US-HMBZ
Study First Received:	July 31, 2002
Last Updated:	July 18, 2006
ClinicalTrials.gov Identifier:	NCT00042562 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:

Depressed
blues
sadness

feelings of guilt
hopelessness
lack of energy

Study placed in the following topic categories:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Fatigue
Depression
Adrenergic Agents
Psychotropic Drugs
Depressive Disorder, Major
Depressive Disorder
Serotonin Uptake Inhibitors

Duloxetine
Serotonin
Behavioral Symptoms
Dopamine
Mental Disorders
Mood Disorders
Dopamine Agents
Antidepressive Agents

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Depression
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs
Depressive Disorder, Major
Depressive Disorder

Serotonin Uptake Inhibitors
Duloxetine
Pharmacologic Actions
Behavioral Symptoms
Serotonin Agents
Mental Disorders
Therapeutic Uses
Mood Disorders
Dopamine Agents
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on July 02, 2009